Clearance Summary
SENSOR AMPLIFIER received FDA 510(k) clearance under submission number K972515, sponsored by Pro-Tech Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-10-02.
- Submission: K972515
- Applicant / Sponsor: Pro-Tech Services, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 1997-10-02
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.